Clinical trial · Observational
Relationships Between Physical Activity and Different Measures of Fatigue in Cancer Survivors
NCT05073848CI-TRIAL-00117298recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Remission | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- BfitBwell Participants
- description
- Individuals in the BfitBwell Cancer Exercise Program complete a FACIT-Fatigue questionnaire at their baseline assessment. This will be screened for all incoming BfitBwell participants and those meeting the inclusion criteria of a score of 48 or less will be approached for interest in participating. The primary research activities beyond recruitment, screening, and informed consent are the collection of EMA fatigue assessments via smartphone application and PA assessment via actigraphy.
Primary outcomes (2)
- measure
- 10-point Fatigue Scale, Day
- timeFrame
- 3 months
- description
- Severity of fatigue experienced over the course of the day, ranked 0-10. How would you rate your fatigue, over the last day, on a scale of 0-10, with 0 being no fatigue and 10 being the worst possible fatigue?
- measure
- Physical Activity measure by Actigraph device
- timeFrame
- 3 months
- description
- PA will be monitored using commonly used, non-invasive Actigraph devices (Actigraph GT3XP). Data will be collected utilizing methodology similar to that of the National Health and Nutrition Examination Survey (NHANES), in cancer survivors. The collected accelerometry data will be downloaded and analyzed in ActiLife software, calculation the average time spent in moderate-to-vigorous (MVPA) at each assessment period using standard algorithms and cut-points.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be an active participant in the BfitBwell Cancer Exercise Program * Criteria for this program include: * Adult (\>= 18 years old) * Being a patient seen at the University of Colorado Cancer Center * Currently receiving cancer therapy or be within 6 months of completing cancer therapy * Have a signed physician clearance form to participate in an exercise program * Have a smartphone (necessary for the EMA assessments) * A score of 48 or less on the FACIT-Fatigue (completed during the initial BfitBwell Program assessment) * The minimally important difference of the FACIT-Fatigue is 3 points, suggesting that a score of at most 48 indicates the presence of CRF and allows for meaningful change in both directions. Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.